Colorectal Cancer
Conditions
Keywords
adenocarcinoma of the colon, stage III colon cancer
Brief summary
RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, leucovorin, and S-1, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving tegafur-uracil together with leucovorin is more effective than giving S-1 in treating patients with stage III colon cancer. PURPOSE: This randomized phase III trial is studying giving tegafur-uracil together with leucovorin to see how well it works compared with giving S-1 in treating patients with stage III colon cancer that has been completely removed by surgery.
Detailed description
OBJECTIVES: * Compare the disease-free survival of patients with stage III colon cancer treated with S-1 or tegafur-uracil and leucovorin after curative surgery . OUTLINE: Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral tegafur-uracil and oral leucovorin 3 times daily on days 1-21. The treatment repeats 5 times every 5 weeks. * Arm II: Patients receive oral S-1 twice daily on days 1-28. The treatment repeats 4 times every 6 weeks. Biological samples are collected for gene expression analysis for identification of predictive markers.
Interventions
Sponsors
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of colon * Stage III (T1-4, N1-3, M0) disease * Has undergone surgical resection of the tumor within the past 8 weeks PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Able to take medications orally * WBC ≥ 3,500/mm³ and \< 12,000/mm³ * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9.0 g/dL * Total bilirubin ≤ 2.0 mg/dL * AST/ALT ≤ 100 IU/L * Creatinine ≤ 1.2 mg/dL * No other active malignancies * Must have none of the following comorbidities: * Severe postoperative complications * Uncontrollable diabetes mellitus * Uncontrollable hypertension * Myocardial infraction within 6 months * Unstable angina pectoris * Hepatocirrhosis * Interstitial pneumonia, pulmonary fibrosis, or severe emphysema PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy for colon cancer * No concurrent radiotherapy * No concurrent biological response modifiers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | — |
| Adverse event | — |
| Pharmaco-economics | — |
| Identification of predictive markers | — |
Countries
Japan
Outcome results
None listed